Expandable intramedullary systems and methods of using the same

ABSTRACT

Intramedullary systems, expandable intramedullary nails, expandable anchors, and methods of using the same. The intramedullary system may include an expandable intramedullary nail configured to extend into an intramedullary canal of a long bone and/or one or more expandable anchors configured to extend at an angle transverse to the intramedullary nail. The intramedullary nails and/or anchors may include one or more integrated expansion mechanisms that allow for insertion in a contracted configuration and expansion into a deployed configuration to lock the relative position and prevent axial rotation and translation of the system.

FIELD OF THE INVENTION

The present disclosure relates generally to expandable intramedullarysystems and methods for treating long bones, and more particularly toexpandable intramedullary nails and anchors that are adapted to preventmovement (e.g., axial rotation and/or translation) of the nail whenimplanted in an intramedullary canal of a long bone.

BACKGROUND

Long bones may generally refer to a femur, tibia, humerus, or other longbone of a mammal, such as a human. For the purpose of clarity, the femurbone will be discussed herein as an example of the deficienciesassociated with traditional intramedullary nails.

As is known in the art, the thighbone of a person is called a femur andthe long, straight part of the femur is called the femoral shaft, theproximal end is known as the hip. When there is a break anywhere alongthe length of the femoral shaft, it is called a femoral shaft fracture.Fractures near the hip are known as hip fractures. There are many typesof fractures, such as transverse fractures, oblique fractures, spiralfractures, commonuted fractures, etc., each of which could be caused byhigh-energy collisions or low-energy geriatric fragility fractures.

Intramedullary nailing is one type of operation that is able to treatthese femoral fractures. This operation typically involves drilling ahole at one end of the femur away from the femoral fracture. Once thehole has been drilled into the femur, a metal nail having a distalportion and a proximal portion is inserted into the hole, with thedistal portion of the nail passing the fracture. To prevent movement ofthe nail, locking of the nail is required.

Historically, this has been accomplished by inserting one or morebicortical bone screws through holes arranged at the distal portion,proximal portion, or along a length of the implanted nail. Onedisadvantage in this technique is that additional incisions are requiredto be made on the patient to insert the bicortical bone screws throughthe holes of the implanted nail to achieve the desired locking. Thistechnique increases the patient's chances of being exposed to infectionand, moreover, moves away from the desire for minimally invasiveoperations. This technique also makes aiming difficult, can be timeconsuming, and may be error prone.

Therefore, there exists a need to provide an intramedullary nail thatcan cure some or many of the deficiencies of more traditional systems.

SUMMARY

To meet this and other needs, expandable intramedullary systems areprovided that have integrated distal locking and/or proximal locking,which are designed to prevent rotation and/or axial movement of theintramedullary nail once implanted. In particular, the intramedullarysystem may include an expandable intramedullary nail or rod and/or oneor more expandable anchors. The intramedullary system may include one ormore integrated expansion mechanisms configured to secure theintramedullary nail in a long bone.

One of the expansion mechanisms may include an expandable distal portionin order to achieve distal locking of the intramedullary nail. Anotherexpansion mechanism may include an expandable proximal anchor configuredto secure the proximal portion of the intramedullary nail. Theseexpandable mechanisms are able to cure certain deficiencies oftraditional intramedullary nails by providing an expandableintramedullary nail and/or expandable anchor. In particular, theexpandable intramedullary nail and/or expandable anchor may be insertedin a contracted state requiring smaller access to the surgical locationwhile also achieving enhanced locking once expanded. In addition, theexpandable intramedullary nail may not require additional incisionsbeing made on the patient to achieve distal locking and the expandableanchor may provide for more robust proximal locking of theintramedullary nail. The expandable intramedullary nail also providesone or more mechanisms that enable a surgeon to perform distal lockingof the intramedullary nail before or after proximal locking has takenplace.

According to one embodiment, the intramedullary system includes anintramedullary nail configured to extend into an intramedullary canal ofa long bone and at least one anchor configured to extend at an angletransverse to the intramedullary nail. The intramedullary nail and/orthe anchor may be provided with expansion mechanisms having contractedand expanded positions.

In an illustrative embodiment, the intramedullary system includes anexpandable intramedullary nail and at least one expandable anchor. Theexpandable intramedullary nail is configured to extend through anintramedullary canal of a long bone. The intramedullary nail comprisesan elongate nail body having a proximal portion and a distal portion. Anelongate adjustment rod extends through the nail body. An actuationmember is configured to move the adjustment rod longitudinally throughthe nail body. The proximal portion has an opening extendingtherethrough, and the distal portion has one or more expandable fixationmembers disposed in the nail body in a contracted position. Uponrotation of the actuation member, the adjustment rod linearly translatesthrough the nail body, and the one or more fixation members radiallyextend from the intramedullary nail to an expanded position to securelyanchor the distal portion of intramedullary nail in the intramedullarycanal. The expandable proximal anchor is positioned through the openingand transverse to the intramedullary nail. The proximal anchor has acannulated elongate body, an actuation mechanism extendinglongitudinally through the elongate body, and at least one expandablesecuring member engaged with the actuation mechanism. The actuationmechanism is configured to deploy the at least one securing member fromthe elongate body upon linear movement of the actuation mechanism.

In an illustrative embodiment, the expandable intramedullary nailcomprises a longitudinal nail body adapted to be inserted into anintramedullary canal of a long bone, such as a femur. The nail body hasa laterally angled through-hole adapted to receive an anchor, such as afemoral neck nail, so as to provide proximal locking of theintramedullary nail to the femur bone. The intramedullary nail furthercomprises an adjustment rod having a distal portion and a proximalportion. The proximal portion is arranged with a lateral opening throughwhich the proximal anchor is received. Because the longitudinal lengthof the lateral opening is longer than the diameter of the receivedproximal anchor, the adjustment rod is able to move longitudinallywithin the nail body. The longitudinal movement of the adjustment rodradially deploys one or more fixation members disposed within the nailbody. The fixation members engage the inner surface of theintramedullary canal (e.g., cortical bone) to prevent axial rotation andtranslation of the intramedullary nail, thereby providing distal lockingof the intramedullary nail to the femur bone without addition incisions.

In another illustrative embodiment, the expandable anchor includes acannulated elongate anchor body having a proximal portion and a distalportion, an elongate actuation mechanism extending longitudinallythrough the anchor body, and configured to move longitudinally throughthe anchor body, and one or more expandable securing members engagedwith the actuation mechanism and disposed in the anchor body in acontracted position. Upon linear translation of the actuation mechanismtoward the distal portion of the anchor body, the one or more securingmembers radially extend from the anchor body to an expanded position tosecurely anchor the distal portion of anchor body.

In yet another illustrative embodiment, a method of securing a long bonemay include inserting an expandable intramedullary nail into anintramedullary canal of a long bone and inserting a proximal anchorthrough the intramedullary nail. The method may include deploying one ormore expandable fixation members from the intramedullary nail byrotating the actuation member and thereby moving the adjustment rodlongitudinally through the nail body, wherein the fixation membersradially extend from the intramedullary nail to an expanded position tosecurely anchor the distal portion of intramedullary nail in theintramedullary canal. If expandable, the method may also includedeploying one or more expandable securing members from the elongate bodyof the anchor by linear movement of the actuation mechanism, wherein thesecuring members radially extend from the anchor to an expanded positionto securely anchor the proximal portion of intramedullary nail in theintramedullary canal.

These advantages of the present invention will be apparent from thefollowing disclosure and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a perspective view of an expandable intramedullary system, ina deployed state, positioned within a long bone according to oneembodiment.

FIG. 2 is a perspective view of the intramedullary nail in anun-deployed state according to an illustrative embodiment.

FIG. 3 is a perspective view of the intramedullary nail of FIG. 2 in adeployed state according to an illustrative embodiment.

FIG. 4 is a top view of the intramedullary nail of FIGS. 2 and 3 inaccordance with an illustrative embodiment.

FIG. 5 depicts the elements that form the intramedullary nail inaccordance with an illustrative embodiment.

FIG. 6 is a perspective view of the inner surface of a fixation memberin accordance with an illustrative embodiment.

FIG. 7 is a perspective view of the outer surface of the fixation memberdepicted in FIG. 6.

FIG. 8 is a perspective view of the distal portion of the adjustment rodin accordance with an illustrative embodiment.

FIG. 9A is a perspective view of one fixation member meshed with anotherfixation member in accordance with an illustrative embodiment.

FIG. 9B is a perspective view of two fixation members being radiallydeployed from intramedullary nail by an adjustment rod in accordancewith an illustrative embodiment.

FIG. 10A is a perspective view and a close up front view of theintramedullary nail in an un-deployed state according to an illustrativeembodiment.

FIG. 10B is a perspective view and a close up front view of theintramedullary nail in a deployed state according to an illustrativeembodiment.

FIG. 11 is a cross-sectional side view of the intramedullary nail ofFIG. 2 in the un-deployed state according to an illustrative embodiment.

FIG. 12 is a cross-sectional side view of the intramedullary nail ofFIG. 3 in the deployed state according to an illustrative embodiment.

FIG. 13 is a cross-sectional side view of the intramedullary nail ofFIG. 11 rotated 90°.

FIG. 14 is a cross-sectional side view of the intramedullary nail ofFIG. 12 rotated 90°.

FIG. 15 is a perspective view of a proximal anchor locked to theintramedullary nail in accordance with an illustrative embodiment.

FIG. 16 is a zoomed-in view of section “A” of the intramedullary nail inthe un-deployed state according to the illustrative embodiment.

FIG. 17 is a zoomed-in view of section “A” of the intramedullary nail inthe deployed state according to the illustrative embodiment.

FIG. 18 is a perspective view of the proximal anchor in an un-deployedstate according to an illustrative embodiment.

FIG. 19 is a side view of the proximal anchor nail of FIG. 18 inaccordance with an illustrative embodiment.

FIG. 20 is a back perspective view of the proximal anchor of FIG. 18 inaccordance with an illustrative embodiment.

FIG. 21 is a perspective view of the proximal anchor of FIG. 18 in adeployed state according to an illustrative embodiment.

FIG. 22 is a side view of the proximal anchor of FIG. 21 in accordancewith an illustrative embodiment.

FIG. 23 is a back perspective view of the proximal anchor of FIG. 21 inaccordance with an illustrative embodiment.

FIG. 24 depicts the elements that form the proximal anchor in accordancewith an illustrative embodiment.

FIG. 25 is a cross-sectional view of the proximal anchor in anun-deployed and deployed state in accordance with an illustrativeembodiment.

FIG. 26 is a perspective view of an intramedullary nail in anun-deployed state according to an alternative embodiment.

FIG. 27 is a perspective view of the intramedullary nail of FIG. 27 in adeployed state according to an alternative embodiment.

FIG. 28 is a perspective view of an end cap adapted to be threaded tothe intramedullary nail of FIG. 27 according to an alternativeembodiment.

FIG. 29 is a perspective view of an adjustment rod disposed within theintramedullary nail of FIG. 27 according to an alternative embodiment.

FIG. 30 is a perspective view of a captivator adapted to couple to theadjustment rod of FIG. 29 according to an alternative embodiment.

DETAILED DESCRIPTION

Embodiments of the disclosure are generally directed to systems,devices, and methods for stabilizing fractures or the like of long bonesand other hollow bones. The intramedullary system may include anintramedullary nail configured to extend into an intramedullary canal ofa long bone and at least one anchor configured to extend at an angletransverse to the intramedullary nail. The intramedullary system mayinclude one or more integrated expansion mechanisms configured to securethe intramedullary nail in the bone. In particular, the intramedullarynail may include an expandable distal portion in order to achieve distallocking of the intramedullary nail. The anchor may be in the form of aproximal anchor configured to extend into a neck portion of the longbone. The anchor may include an expandable proximal anchor configured tosecure the proximal portion of the intramedullary nail. The expandableintramedullary nail and expandable anchor may be used together incombination or each may be used separately with traditionalintramedullary nails or anchors, respectively.

It will be appreciated by those of skill in the art that a long bone mayinclude any bone that is longer than it is wide. Examples of long bonesmay include, but are not limited to the femur, tibia, fibula, humerus,radius, ulna, and phalanges. The description herein generally refers totreatment of a femur, but the systems, devices, and methods may beequally applied to any other long or hollow bone structure. It is alsocontemplated that the expansion mechanisms described herein may haveapplicability in other areas including those outside of long boneapplications.

The embodiments of the disclosure and the various features andadvantageous details thereof are explained more fully with reference tothe non-limiting embodiments and examples that are described and/orillustrated in the accompanying drawings and detailed in the followingdescription. The features of one embodiment may be employed with otherembodiments as the skilled artisan would recognize, even if notexplicitly stated herein. Descriptions of well-known components andprocessing techniques may be omitted so as to not unnecessarily obscurethe embodiments of the disclosure. The examples used herein are intendedmerely to facilitate an understanding of ways in which the disclosuremay be practiced and to further enable those of skill in the art topractice the embodiments of the disclosure. Accordingly, the examplesand embodiments herein should not be construed as limiting the scope ofthe disclosure, which is defined solely by the appended claims andapplicable law. Moreover, it is noted that like reference numeralsrepresent similar features and structures throughout the several viewsof the drawings.

Intramedullary System

Referring now to FIG. 1, the intramedullary system 10 may include anintramedullary nail 100 in combination with one or more anchors 200. Theintramedullary system 10 may include an intramedullary nail 100configured to extend into an intramedullary canal or positioned into themedullary cavity of a bone. Although described as a nail, it will beappreciated that the intramedullary nail 100, also known as an IM nail,may be in the form of a rod, shaft, elongate member, or the like. Theanchor 200 may be configured to extend at an angle transverse to theintramedullary nail 100. As will again be appreciated, the anchor 200may be in the form of a screw, nail, rod, shaft, elongate member, or thelike. Depending on the position, number, and type of anchors, the anchor200 may be positioned at any suitable angle or orientation relative tothe intramedullary nail 100. When positioned at a proximal location ofthe intramedullary nail 100 to provide for proximal fixation of theintramedullary nail 100, the anchor 200 may be positioned at an anglesuch that the distal end of the anchor 200 extends upwards into the neckportion of the long bone (e.g., the femoral neck of a femur). One of thesignificant advantages of the intramedullary system 10 over othersystems and methods of fixation is the intramedullary system 10 sharesthe load with the bone, rather that entirely supporting the bone. Due tothis load sharing, patients may be able to use the extremity morequickly. In addition, with the expandable components described herein,the patient may require smaller and/or fewer incisions (e.g., thosetypically needed for the placement of larger fixation devices and/ormultiple fixation points) leading to improved patient outcomes andhealing times.

The intramedullary system 10 may include one or more integratedexpansion mechanisms configured to secure the intramedullary nail 100and/or anchor 200 in the bone once expanded. In addition, when in acontracted position, the integrated expansion mechanism allows for asmaller surgical access window to insert the device. In particular, theintramedullary nail 100 may include an expandable distal portion 140 inorder to achieve distal locking of the intramedullary nail 100. Theproximal portion 142 of the intramedullary nail 100 may be secured withone or more traditional bone nails, screws, or the like (not shown). Inthe alternative, the proximal portion of the intramedullary nail 100 maybe secured with the expandable anchor 200 configured to extend into theneck portion of the long bone (e.g., the femoral neck of the femur),thereby securing the proximal portion 142 of the intramedullary nail 100once expanded. The expandable proximal anchor 200 can also be used witha traditional, non-expandable intramedullary nail or rod (not shown).Although one anchor 200 is exemplified herein, it will be appreciatedthat additional anchors including traditional anchors and/or expandableanchors may be used in the intramedullary system 10. In addition,although one expansion mechanism is described with respect to theintramedullary nail 100 and another expansion mechanism is describedfurther with respect to the proximal anchor 200, it will be appreciatedthat the expansions mechanisms may be switched or modified in order toachieve the desired fixation in the bone.

Expandable Intramedullary Nail

According to one embodiment, the intramedullary nail 100 includes anexpandable distal portion 140 in order to achieve distal locking of theintramedullary nail 100. The expandable intramedullary nail 100 isconfigured to be inserted into the intramedullary canal of a long bonewhile in a contracted or un-deployed state. FIG. 2 is a perspective viewof one version of the intramedullary nail 100 in an un-deployed state.After the intramedullary nail 100 has been positioned in the long bone,the intramedullary nail 100 can be actuated, for example, usingmechanical actuation, to expand or deploy the expandable distal portion140 to an expanded or deployed state. FIG. 3 is a perspective view ofintramedullary nail 100 in a deployed state. Unlike other devices whichmay use an inflatable device or cavity, for example, filled with bonecement or the like in order to expand a portion of the intramedullarynail, the expandable intramedullary nail 100 relies on one or moremechanically actuated mechanisms to expand the expandable distal portion140.

In the embodiment shown in FIGS. 2 and 3, expandable distal portion 140of the intramedullary nail 100 includes one or more expandable ordeployable fixation members 108, 110. In particular, as shown, theintramedullary nail 100 includes a cannulated elongate sleeve 102, acannulated longitudinal nail body 104 having at least one lateralthrough-hole 106, a first expandable fixation member 108, and a secondexpandable fixation member 110. Although two fixation members 108, 110are shown, it is envisioned that any suitable number, size, and type offixation members may be selected to obtain the desired fixation andpress-fit type anchoring when expanded in the intramedullary canal. Inparticular, the expandable distal portion 140 may include one or moreplates, projections, extensions, spikes, teeth, pointed members, or thelike configured to emerge from within the intramedullary nail body 104.Moreover, the fixation members 108, 110 may be generally flat,contoured, provided with surface roughening or teeth, or have anycharacteristics to enhance locking of the distal portion 140 of theintramedullary nail 100 when expanded.

In addition, unlike other devices which may use a shape-memory alloy orother shape-memory technique for the fixation members to automaticallydeploy from the device, the expandable intramedullary nail 100 isconfigured such that the expandable distal portion 140 radially expandsfrom the nail 100 with continuous and/or discrete adjustments. In otherwords, the expandable distal portion 140 is uniquely controlled suchthat the fixation members 108, 110 can be deployed to any desired amountwithout requiring full deployment. Since the expansion of theintramedullary nail 100 is actuated by a rotational input, the expansionof the intramedullary nail 100 is infinite. In other words, the fixationmembers 108, 110 can be expanded to an infinite number of heightsdependent on the rotational advancement of the actuation member, such asa drive screw 120. Thus, the fixation members 108, 110 can be deployedto the degree necessary to achieve the desired press-type fit in theintramedullary canal without providing too much stress on the bone.

As shown in FIG. 2, the first fixation member 108 is disposed within adistal portion of longitudinal nail body 104. Although not shown in FIG.2, second fixation member 110 is similarly disposed within nail body104. In this embodiment, the first and second fixation members 108, 110have a plate-like or elongated shape. In particular, the first andsecond fixation members 108, 108 have a length greater than their width.The first and second fixation members 108, 110 have an outer surfacethat is substantially planar with a slight curve to conform to thecircular cross-sectional shape of nail body 104. The planar surfaces offixation members 108, 110 may be arranged with teeth having a profilethat lies substantially on the same plane as the outer surface of nailbody 104 when fixation members 108, 110 are disposed within the nailbody 104. This allows a surgeon to more easily insert nail 100 into anintramedullary canal of a femur bone.

The first and second fixation members 108, 110 may be positioned at anysuitable location along the length of the nail body 104. The nail body104 may terminate in a tip 111. The tip 111 may be rounded, curved, orsubstantially blunt, as shown. Preferably, the first and second fixationmembers 108, 110 are positioned at a distal-most end of the body 104,for example, proximate to the tip 111. It is envisioned, however, thatadditional fixation members 108, 110 may be provided along the length ofthe body 104, for example, substantially centrally along the length ofthe body 104 or closer to the proximal portion 142. Due to themechanical functionality of the first and second fixation members 108,110, the overall length of the nail 100 does not change when thefixation members 108, 110 are expanded. In addition, the dimensions ofthe fixation members 108, 110 do not change or alter when they areexpanded (although more of the fixation member 108, 110 protrudes fromthe body 104 when expanded).

In one embodiment, the nail body 104 is inserted into the intramedullarycanal such that the first and second fixation members 108, 110 pass thefemoral fracture of the femur bone. The nail body 104 is inserted insuch a way that lateral through-hole 106 of nail body 104 is alignedwith the neck of the femur bone. Once the nail body 104 has beensituated in the intramedullary canal, a femoral neck nail or proximalanchor 200 is inserted through lateral through-hole 106, which extendsinto a hole that has been drilled into the femur neck. The femoral necknail may be locked to nail body 104, thereby providing proximal lockingof the nail body 104 to the femur bone. The femoral neck nail can be,for example, and without limitation, a threaded or non-threaded anchor,lag screw, nail, or the like. In other embodiments, discussed in moredetail herein, the femoral neck nail is an expandable proximal anchor200 having one or more securing members 202, 204 that are adapted toradially deploy from the body of the proximal anchor 200 into thefemoral neck. In any case, the mechanism for locking proximal anchor 200to body 104 will be described in more detail below, with respect to FIG.11. Thereafter, an adjustment rod 116 (shown in FIG. 5) coupled tofixation members 108, 110 is moved, retracted, driven, etc.,longitudinally towards the proximal portion 142 of nail body 104. Movingadjustment rod 116 in a longitudinal manner causes the first and secondfixation members 108, 110 to be radially deployed from the nail body104, as shown at the bottom of FIG. 4. In accordance with theillustrative embodiment, first and second fixation members 108, 110 areadapted to be simultaneously deployed from nail body 104 to providedistal locking of the nail body 104 to the shaft of the femur bone. Onthe other hand, moving adjustment rod 116 longitudinally towards thedistal portion of nail body 104 causes the first and second fixationmembers 108, 110 to be radially retracted into nail body 104, as shownat the top of FIG. 4. Adjustment rod 116 will be described in moredetail below, with respect to FIGS. 8-14.

Although intramedullary nail 100 has been generally described above asbeing used on a femur bone, it will be clear to those skilled in theart, after reading this disclosure, that the intramedullary nail 100 canalso be used on any long bone. For example, and without limitation,intramedullary nail 100 can be used on a tibia bone, a humerus bone,etc., without departing from the scope of the present invention.

The intramedullary nail 100 may be preferably made of a biocompatiblemetal, such as titanium or titanium alloys. However, it will be clear tothose skilled in the art, after reading this disclosure, how to make anduse alternative embodiments of the invention in which intramedullarynail 100 is made from biocompatible plastics (e.g., polyetheretherketone(PEEK), etc.) or a combination of biocompatible metals and plastics, forexample.

FIG. 4 is a top view of intramedullary nail 100 of FIGS. 2 and 3. Asshown in the top figure, first and second fixation members 108, 110 arerespectively disposed within a first opening 112 and a second opening114 of nail body 104. The openings 112, 114 can be seen more clearly inFIG. 5. The openings 112, 114 are, for example, and without limitations,slots, recesses, windows, etc., that are sized and shaped to receivefixation members 108, 110, respectively, when they are radiallyretracted into the nail body 104 by adjustment rod 116. This featurewill be discussed in more detail below, with respect to FIGS. 5 and9-14.

The bottom of FIG. 4 depicts the nail body 104 in a deployed state, inwhich the first and second fixation members 108, 110 have been extendedoutside of the openings 112, 114, respectively, by adjustment rod 116.When the fixation members 108, 110 are radially deployed from theirrespective openings 112, 114, the teeth arranged on the outer planarsurfaces of the fixation members 108, 110 engage the inner surface ofthe intramedullary canal (e.g., cortical bone), thereby providing apress-fit type connection and locking. As will be discussed in moredetail below, with respect to FIGS. 11-14, the force in which fixationmembers 108, 110 engage the inner surface of the intramedullary canalcan be adjusted (i.e., increased or decreased) by longitudinally movingadjustment rod 116 further back towards the proximal or distal portionsof nail body 104.

Although the first and second fixation members 108, 110 are adapted tosimultaneously transition between an un-deployed state and a deployedstate, it will be clear to those skilled in the art after reading thisdisclosure, how to make and use alternative embodiments of the inventionin which fixation members 108, 110 are adapted to individuallytransition between an un-deployed state and a deployed state. Inaddition, only one fixation member may be deployed or more than twofixation members may be deployed.

FIG. 5 is an exploded view of the intramedullary nail 100 and theelements that may form the intramedullary nail 100. The intramedullarynail 100 may include an elongate nail body 104, an expandable distalportion 140 (e.g., including one or more fixation members 108, 110), anelongate adjustment rod 116 configured to extend through the nail body104 and configured to move the expandable distal portion 140, and anactuation mechanism (e.g., one or more screws) configured to move theadjustment rod 116 longitudinally through the nail body 104.

The intramedullary nail 100 may include an elongate nail body 104 havingan opening extending longitudinally therethrough. The nail body 100 maybe generally cylindrical in shape or may have any other suitablecross-sectional shape. The nail body 100 may have a larger diameter atthe proximal portion 142 and may transition to a smaller diameter at thedistal end. Arranged at the distal end of nail body 104 are openings112, 114, each of which is sized and shaped to accommodate the fixationmembers 108, 110. Specifically, FIG. 5 shows opening 112 sized andshaped to receive the first fixation member 108, while opening 114 issized and shaped to receive the second fixation member 110. The fixationmembers 108, 110 are shown in more detail in FIGS. 6 and 7, which willnow be discussed. It should be noted at this point of the disclosurethat first fixation member 108 and second fixation member 110 are mirrorimages of each other. For the purpose of clarity, the followingdiscussion of FIGS. 6 and 7 will use the generic word “fixation member500” to refer to both first and second fixation members 108, 110.

FIG. 6 is a perspective view of the inner surface 117 of fixation member500. The fixation member 500 is preferably made of a biocompatiblematerial, such as a biocompatible metal or biocompatible plastic, suchas PEEK. The inner surface 117 of the fixation member 500 has aplurality of spaced apart tabs 128 that extend orthogonally from, andalong longitudinal edges of, the inner surface 117. The tabs 128 arespaced apart in such a way to allow tabs of one fixation memberinterleave, mesh, etc., with tabs of another fixation member afteradjustment rod 116 moves longitudinally within nail body 104. As shown,the fixation member 500 may have two spaced apart tabs 128 extendingfrom one edge of the fixation member 500 and two spaced apart tabs 128extending from the other edge of the fixation member 500. Although twotabs 128 are shown on each edge more or less tabs 128 may be usedinstead.

Each tab 128 includes at least one ramp or angled surface having aslope. In particular, an inner surface of each tab 128 is arranged withat least one ramp or angled surface having a slope or angle relative tothe longitudinal axis of the nail body 104. The ramps or angled surfacesmay be in the form of one or more grooves, recesses, projections,protrusions, or the like in the tab 128. The ramp or angled surface mayextend from a first end of the tab 128 to a second, opposite end of thetab 128. Although one ramp per tab is exemplified in the figures, itwill be appreciated that multiple ramps or angled surfaces may beprovided for each tab 128. In addition, it is contemplated that theslope of the ramped surfaces on each tab 128 can be equal or can differfrom one another. The ramps can serve to move the fixation members 108,110 when the adjustment rod 116 is linearly translated between thefixation members 108, 110. In other words, as the adjustment rod 116moves, the ramped surfaces 134, 136 of the adjustment rod 116 pushagainst the ramped surfaces of the fixation member 108, 110 pushing thefixation members 108, 110 outwardly into the expanded position. Itshould also be noted that the expansion of the fixation members 108, 110can be varied based on the differences in the dimensions of the rampedsurfaces. The fixation members 108, 110 can be expanded in any of thefollowing ways, for example: straight rise expansion, angled riseexpansion, straight rise expansion followed by an angled toggle, or aphase off straight rise.

In one embodiment, each of the tabs 128 has an inner surface that isarranged with an angled surface in the form of a groove 130, with eachgroove 130 having a predetermined angle relative to a longitudinal axisof nail body 104. The predetermined angle can range, for example, fromabout 20° to 40° or about 25° to 35° relative to the longitudinal axisof nail body 104. In one embodiment, the predetermined angle can beabout 30° relative to the longitudinal axis of nail body 104. It shouldbe noted that changing the orientation of the fixation member 500 shownin FIG. 6 (e.g., a bottom fixation member) to the orientation shown inFIG. 7 (e.g., a top fixation member) would change a 30° angle of thegroove to about 120°.

FIG. 7 is a perspective view of an outer surface 132 of the fixationmember 500 depicted in FIG. 6. As shown in this figure, outer surface132 is substantially planar with a slight curve. This curvature enablesthe outer surface 132 of the fixation member 500 to conform to thecircular shape of nail body 104 when the fixation member 500 is disposedwithin the nail body 104 and in the contracted position. The planarouter surface 132 of the fixation member 500 may be arranged with asurface roughening, such as teeth 126 or the like having a profile thatlies substantially on the same plane as the outer surface of nail body104 when the fixation member 500 is disposed within nail body 104 in thecontracted position. That is, the fixation member 500 is able to retractinto the axial profile of the nail body 104 (e.g., ≤Ø9 mm on a Ø9 mmnail) for insertion into the intramedullary canal of a long bone, suchas a femur bone.

The adjustment rod 116 includes at least one ramp or angled surfacehaving a slope sized and configured to mate with the corresponding rampson the tabs 128 of the fixation members 108, 110. In particular, anouter surface on each side of the adjustment rod 116 is arranged with atleast one ramp or angled surface having a slope or angle relative to thelongitudinal axis of the adjustment rod 116. The ramps or angledsurfaces may be in the form of one or more grooves, recesses,projections, protrusions, or the like in the adjustment rod 116, whichare configured to correspond to those of the tab 128.

In one embodiment, FIG. 8 is a perspective view of a distal portion ofthe adjustment rod 116. The distal portion of the adjustment rod 116 isarranged with a first plurality of angled tongues 134 and a secondplurality of angled tongues 136 configured to engage with thecorresponding angled grooves 130 of the first and second fixationmembers 108, 110, respectively. The tongues 134, 136 may be in the formof extensions or protrusions projecting from an outer surface of theadjustment rod 116 or may be formed or defined by triangular cut-outs orrecesses in the adjustment rod 116. The adjustment rod 116 may be solidor may be cannulated along its length and may extend generally to thetip 111 of the nail 100, for example, when in the contracted position.

Although the ramps on the adjustment rod 116 exemplified in the figures,it will be appreciated that one or more ramps or angled surfaces may beprovided having the same or different orientations. The ramps can serveto move the fixation members 108, 110 when the adjustment rod 116 islinearly translated between the fixation members 108, 110. Thus, as theadjustment rod 116 moves, the ramped surfaces 134, 136 of the adjustmentrod 116 push against the ramped surfaces of the fixation member 108, 110pushing the fixation members 108, 110 outwardly into the expandedposition.

By way of example, as best seen in FIGS. 9 and 10, the distal portion ofadjustment rod 116 may be arranged with the second plurality of tongues136 having a predetermined angle which corresponds substantially to thepredetermined angle of the grooves 130 in the tabs 128 of the firstfixation member 108. In the case where the predetermined angle of thegrooves 130 is about 120°, for example, for the top or upper fixationmember 108 (e.g., FIG. 7), the tongues 134 have a corresponding angle ofabout 120°. Similarly, the distal portion of the adjustment rod 116 maybe arranged with the first plurality of tongues 134 having apredetermined angle which corresponds substantially to the predeterminedangle of the grooves 130 in the tabs 128 of the second fixation member110. In the case where the predetermined angle of the grooves 130 isabout 30°, for example, for the bottom or lower fixation member 110(e.g., FIG. 6), the tongues 134 have a corresponding angle of about 30°.

The first plurality of tongues 134 are sized and shaped to be receivedby grooves 130 arranged on tabs 128 of the second fixation member 110(as shown in FIGS. 9 and 10). The second plurality of tongues 136 aresized and shaped to be received by grooves 130 arranged on tabs 128 ofthe first fixation member 108 (as shown in FIGS. 9 and 10). Each tongue134, 136 is adapted 130 to slide along its respective groove 130 toradially retract or deploy the first and second fixation members 108,110, respectively, from the nail body 104 when the adjustment rod 116 isslid relative to the fixation members 108, 110. In particular, thefixation members 108, 110 can be retracted or deployed as adjustment rod116 is moved longitudinally within the nail body 104. In particular, asthe adjustment rod 116 is translated proximally, the fixation members108, 110 are configured to extend radially outward into theintramedullary canal. When the adjustment rod is translated distally,the fixation members 108, 110 are configured to retract inward into thebody 104 of the intramedullary nail 100. It will be clear to thoseskilled in the art, after reading this disclosure, how to make and usealternative embodiments of the present invention including those inwhich tongues 134, 136 are arranged on tabs 128 and grooves 130 arearranged on the adjustment rod 116, instead.

FIG. 9A is a perspective view of first fixation member 108 meshed withsecond fixation member 110 when in an un-deployed or contractedconfiguration. As shown in the figure, the spaced apart tabs 128 offirst fixation member 108 are interleaved or intermeshed with the spacedapart tabs 128 of second fixation member 110. In this configuration,first and second fixation members 108, 110 are disposed within nail body104 and in their respective openings 112, 114, as shown at the top ofFIG. 4. When in the contracted configuration, the tabs 128 are alignedsuch that there is minimal or no gap between the first and secondfixation members 108, 110. Also, the tabs 128 may be configured suchthat a substantially solid outer wall forms when the nail is in theretracted position such that tissue, etc. does not become trapped in thedevice when inserted into the intramedullary canal. Although the tabs128 are depicted as substantially rectangular in shape with adovetail-like configuration, it is envisioned that other configurationscould also provide for a dovetail design (e.g., t-shaped, triangular,curvilinear, or scalloped), thereby allowing the fixation members 108 tomate together when the retracted position.

FIG. 9B is a perspective view of the first and second fixation members108, 110, for example, when radially deployed from the nail body 104 bythe adjustment rod 116. As the adjustment rod 116 is moved towards aproximal portion of nail body 104, the first and second fixation members108, 110 radially extend outside of openings 112, 114, respectively, asshown at the bottom of FIG. 4. Thus, upon the linear movement of theadjustment rod 116, the first and second fixation members 108, 110discretely and continuously expand outside the nail body 104 to anchorthe distal end of the intramedullary nail 100 in the bone.

FIG. 10A shows a perspective view of the intramedullary nail 100including a close-up front view with the first and second fixationmembers 108, 110 in an un-deployed state. As is evident, in the frontview, the first and second fixation members 108, 110 are recessed in thenail body 104. FIG. 10B shows a perspective view of the intramedullarynail 100 including a close-up front view with the first and secondfixation members 108, 110 in a deployed state. As is evident, in thefront view, the first and second fixation members 108, 110 protrudeoutwardly from the nail body 104.

FIG. 11 is a cross-sectional side view of the intramedullary nail 100 ofFIG. 2 in the un-deployed state. In accordance with the illustrativeembodiment, a femoral neck nail or proximal anchor 200 is configured tobe received in the lateral through-hole 106 to provide proximal lockingof the nail body 104 to the femur bone. This is best seen in FIG. 15.The lateral through-hole 106 may be provided at an angle relative to thenail body 104. In particular, the lateral through-hole 106 may be ±10°,±20°, ±30°, ±40°, ±50°, or ±60° off perpendicular. The received necknail or anchor 200 may be locked in the through-hole 106 by a press-fittype connection.

In an alternative embodiment, the received neck nail or anchor 200 maybe locked to through-hole 106 (thus nail body 104) by an optionallocking screw 118. Although the locking screw 118 is exemplified in theembodiments herein, the locking screw 118 may be omitted, for example,if the anchor 200 is secured in the through-hole 106 by a press-fit orother suitable securing mechanism. By way of example, if present, thelocking screw 118 may be rotated towards through-hole 106 to secure theanchor 200 in the through-hole 106. Locking screw 118 is located abovethrough-hole 106 and has an outer surface that is arranged with threads,which are adapted to be threaded against the threads arranged on aninner surface of nail body 104. As shown in FIG. 11, only a smallportion of the inner surface of nail body 104 may arranged with threadsso as to restrict the longitudinal movement of locking screw 118 withinnail body 104.

More specifically, locking screw 118 may be threaded (e.g., clockwise orcounter-clockwise) by a locking tool that enters from an openingarranged at a proximal portion of nail body 104. The locking tool can bean electrically powered tool or a non-electrically powered tool (e.g.,manual). In either case, because the size of the head is smaller thanthe through-hole of drive screw 120, the head of the locking tool isable to pass through the through-hole, out the other side of drive screw120, and engage the recess arranged on locking screw 118. Once the headof the locking tool is received by the recess, the surgeon can rotatelocking screw 118 so that an underside of the locking screw engages theouter surface of femur neck screw 200. This effectively locks proximalanchor 200 to nail body 104, thereby providing proximal locking of thenail body to the femur bone. In the illustrative embodiment, the shapeof the tool head and the recess is torx-shaped. However, other shapescan be used without departing from the scope of the invention so long asboth the tool head and the recess have a complementary shape. Theproximal anchor 200 may be locked to the nail body 104 before or afterdistal locking (e.g., deployment of the expandable distal portion 140)of the nail body 104 to the femur bone.

To achieve distal locking of the intramedullary nail 100, adjustment rod116 is moved longitudinally within the nail body 104. The adjustment rod116 may be actuated by any suitable actuation member or mechanism. Inone embodiment, the adjustment rod 116 may be linearly translated byrotating an actuation member, such as a drive screw 120, housed withinthe adjustment rod 116 or housed within the nail body 104. Thus, theactuation member may allow for rotational movement to cause linearmovement of the adjustment rod 116 (e.g., pulling the adjustment rod 116toward the actuation member). It is envisioned, however, that anysuitable mechanical actuation mechanism may be selected in order tolinearly translate the adjustment rod 116 proximally or distally withrespect to the nail body 104. In addition, if desired, a ratchetingmechanism or the like may be used to cause for movement in a singledirection. The movement of adjustment rod 116 will now be discussed inmore detail in accordance with the embodiment illustrated.

Adjustment rod 116 is housed within nail body 104. The length ofadjustment rod 116 runs from a distal portion of nail body 104 to aproximal portion of nail body 104. The distal portion of adjustment rod116 is coupled to the first and second fixation members 108, 110, forexample, by the tongue-and-groove features described above, with respectto FIGS. 6-8. The proximal portion of adjustment rod 116 has a lateralopening 119 through which locked proximal anchor 200 may be received.The lateral opening 119 has a longitudinal length that is longer than adiameter of the received proximal anchor 200 to allow longitudinalmovement of adjustment rod 116 relative to nail body 104. Morespecifically, and with reference to FIGS. 16 and 17, the proximalportion of adjustment rod 116 has a pair of oppositely positionedextension members 123. The empty space located between the extensionmembers 123 may form the lateral opening 119, which has a longitudinallength that is longer than the diameter of the received proximal anchor200. In the illustrative embodiment, the pair of oppositely positionedextension members 123 is similar to the U-shaped prongs of a tuningfork, for example. The prongs essentially go around the outer surface ofthe received proximal anchor 200 and the locking screw 118 so that theadjustment rod 116 can move longitudinally within nail body 104. Thiscan be seen in the close-up portion “A” of FIGS. 16 and 17. It should benoted that locking screw 118 is not threaded to the extension members123. Rather, locking screw 118 is only threaded to the inner surface ofnail body 104. In other embodiments, lateral opening 119 is athrough-hole (having a longitudinal length that is longer than thediameter of the received proximal anchor 200) arranged at the proximalportion of adjustment rod 116. In either case, lateral opening 119allows proximal anchor 200 to enter nail body 104 from one side, passthrough adjustment rod 116, and extend out the other side of nail body104, to anchor into the femur neck.

The inner surface of lateral opening 119 of the adjustment rod 116 maybe arranged with threads 122 that are threaded to a drive screw 120. Asthe drive screw 120 is rotated, the adjustment rod 116 is lineartranslated toward the drive screw 120. The drive screw 120 may beaxially captivated to prevent axial translation while allowing rotation.For example, the drive screw 120 may be adapted to be rotated (e.g.,clockwise or counter-clockwise) by a drive tool when resting on shoulder129 (see FIGS. 13 and 14) of nail body 104, such that rotation of thethreaded drive screw 120 causes longitudinal movement of adjustment rod116 relative to a longitudinal axis of nail body 104. In more detail,drive screw 120 has a longitudinal through-hole that is, for example,and without limitation, torx-shaped. The through-hole of drive screw 120is adapted to receive a correspondingly shaped head of a drive tool thatenters from an opening arranged at a proximal portion of nail body 104.The drive tool can be an electrically powered tool or a non-electricallypowered tool (e.g., manual). In either case, once the tool head isreceived in the recess, drive screw 120 is rotatable by the surgeon.When rotated, the threads arranged on the outer surface of drive screw120 are threaded against threads 122 of the lateral opening 119 of theadjustment rod 116. As the drive screw 120 is being rotated, anunderside of the drive screw 120 rotatably abuts against shoulder 129.In the illustrative embodiment, the shoulder is formed by the differencein diameter between the space occupied by drive screw 120 and the spaceoccupied by locking screw 118. As shown in more clearly in FIGS. 13 and14, the diameter of the space occupied by drive screw 120 is larger thanthat of locking screw 118. Thus, it can be said that shoulder 129 isformed by the transition in diameter difference between these twospaces.

Since the space occupied by drive screw 120 may be smaller than thespace occupied by locking screw 118, the diameter of drive screw 120 mayalso smaller than the diameter of locking screw 118. Alternatively, thespace occupied by locking screw 118 may be smaller than the spaceoccupied by drive screw 120, the diameter of the locking screw 118 mayalso smaller than the diameter of drive screw 120. This can be seen moreclearly in FIGS. 13 and 14. As briefly discussed above, the surgeon canaccess locking screw 118 by using a locking tool. The locking tool issmaller than the diameter of the longitudinal through-hole of drivescrew 120 and, because of this, the locking tool is able to pass throughthe longitudinal through-hole of drive screw 120 and be received by arecess of locking screw 118. The threaded locking screw 118 is adaptedto be threaded towards the received proximal anchor 200 by the lockingtool to lock the proximal anchor 200 to nail body 104, as discussedabove with respect to FIG. 11.

Depending on the direction of rotation of drive screw 120, adjustmentrod 116 either moves longitudinally towards the proximal portion or thedistal portion of nail body 104. In accordance with the illustrativeembodiment, driving adjustment rod 116 from a distal portion of nailbody 104 to the proximal portion of the nail body in the mannerdiscussed above causes fixation members 108, 110 to radially deploy outof openings 112, 114, respectively. This can be seen in FIG. 12 whencompared to FIG. 11. When fixation members 108, 110 are radiallydeployed from nail body 104, the teeth arranged on their outer surface132 contact the inner surface of the intramedullary canal (e.g., engagethe cortical bone). On the other hand, driving adjustment rod 116 fromthe proximal portion of nail body 104 to the distal portion of the nailbody in the manner discussed above causes fixation members 108, 110 toradially retract into openings 112, 114, respectively. This can be seenby comparing FIG. 12 to FIG. 11.

As best seen in FIGS. 11 and 13, the nail body 104 may be arranged witha pair of oppositely positioned grooves 138 that are sized and shaped toreceive a respective one of extension members 123 to prevent axialrotation of adjustment rod 116. In the illustrative embodiment, each ofthe grooves 138 is longer than its respective extension member 123. Thisconfiguration allows the extension members to slide back and forthwithin their respective groove 138 when adjustment rod 116 moveslongitudinally within nail body 104, as discussed above. For example,when adjustment rod 116 is driven towards the proximal end of nail body104 by the drive tool, each extension member 123 will slide in the samedirection in their respective groove 130. This can be seen more clearlyby comparing FIG. 11 to FIG. 12.

Thus, the adjustment rod 116 actuates the expandable distal portion 140of the intramedullary nail 100, for example, in the form of one or morefixation members 108, 110, in order to achieve distal locking in theintramedullary canal. After the intramedullary nail 100 has beenpositioned in the long bone in an un-deployed position, theintramedullary nail 100 can be actuated to expand or deploy theexpandable distal portion 140 to the deployed position. The distal endof the nail 100 expands to create a press-fit in the inner area of theintramedullary canal, thereby securing or anchoring the intramedullarynail 100 in position.

Expandable Anchor

According to one embodiment, the expandable anchor 200 includes anexpandable distal portion 250 in order to achieve distal locking of theexpandable anchor 200. The expandable anchor 200 is configured to beinserted transverse or crosswise into the intramedullary canal of a longbone while in a contracted or un-deployed state. In particular, theexpandable anchor 200 may be especially configured to be at leastpartially inserted at an angle into the neck of the long bone (e.g., thefemoral neck of a femur). FIG. 18 is a perspective view of one versionof the expandable anchor 200 in an un-deployed state. After theexpandable anchor 200 has been positioned in the long bone, theexpandable anchor 200 can be actuated, for example, using mechanicalactuation, to expand or deploy the expandable distal portion 250 to anexpanded or deployed state. FIG. 21 is a perspective view of theexpandable anchor 200 in a deployed state.

Traditional hip screws or proximal femoral nails may require theplacement of an anchor or lag screw into the femoral neck to preventfemoral head cut-through and to aid in rotational stability and fracturereduction. Historically, this has been accomplished with one large bolt,multiple smaller screws, or a helical blade, for example. Traditionalconcepts may be limited, however, in the available diameter by thediameter of the hole in the proximal nail. To meet this and other needs,expandable intramedullary systems are provided that have integrateddistal locking and/or proximal locking, which are designed to preventrotation and/or axial movement of the intramedullary nail onceimplanted.

To cure at least some deficiencies of traditional anchors, the proximalanchor 200 is provided with one or more expandable or deployablesecuring members 202, 204 (e.g., a pair of securing members 202, 204)that are able to retract into the axial profile of the proximal anchor200 for insertion (e.g., <Ø7.5 mm on a Ø7.5 mm anchor), as shown inFIGS. 18-20. After insertion, the securing members 202, 204 are able toexpand radially into the femoral neck, as shown in FIGS. 21-23. Unlikeother devices which may use a shape-memory alloy or other shape-memorytechnique for the securing members to automatically deploy from thedevice, the expandable anchor 200 is configured such that the expandabledistal portion 250 expands outwardly from the anchor 200 with continuousand/or discrete adjustments. In other words, the expandable distalportion 250 is uniquely controlled such that the securing members 202,204 can be deployed to any desired amount without requiring fulldeployment. Thus, the securing members 202, 204 can be deployed to thedegree necessary to achieve the desired press-type fit connectionwithout providing too much stress on the bone. In addition, unlike otherdevices which may use an inflatable device or cavity, for example,filled with bone cement or the like in order to expand a portion of theanchor, the expandable anchor 200 relies on one or more mechanicallyactuated mechanisms to expand the expandable distal portion 250. Due tothe mechanical functionality of the securing members 202, 204, theoverall length of the anchor 200 does not change when the securingmembers 202, 204 are expanded. In addition, the dimensions of thesecuring members 202, 204 do not change or alter when they are expanded(although more of the securing members 202, 204 protrude from the anchor200 when expanded or deployed).

In the embodiment shown in FIGS. 18-25, the expandable anchor 200includes a cannulated elongate body, an actuation mechanism includingadjustment member 220 and deployment member 240 extending longitudinallythrough the elongate body, a first expandable securing member 202, and asecond expandable securing member 204. The anchor 200 may terminate in atip 211. The tip 211 may be rounded, curved, or substantially blunt. Thetip 211 of the anchor 200 may house one or more pins 270. Whenassembled, the pin 270 may engage a recess in the securing members 202,204 in the contracted position. When fully deployed, the pin 270 mayengage a portion of the deployment member 240.

As shown in FIGS. 21-23, the securing members 202, 204 extend from adistal portion of the body of the anchor 200 when deployed. The body ofthe proximal anchor 200 has slots 206, 208 cut out at the distal portionof the proximal anchor 200 where at least two expandable securingmembers 202, 204 are inserted and extend therethrough in the expandedposition. In accordance with the illustrative embodiment, each of theexpandable securing members 202, 204 is a rectangular-shaped paddle,plate, etc. In this embodiment, the securing members 202, 204 have aplate-like or elongated shape. In particular, the securing members 202,204 have a length greater than their width. The securing members 202,204 may extend a suitable distance from the body of the anchor 200. Thesecuring members 202, 204 may be positioned at any suitable locationalong the length of the anchor 200. Preferably, the securing members202, 204 are positioned at a distal-most end of the anchor 200, forexample, proximate to the tip 211. It is envisioned, however, thatadditional securing members 202, 204 may be provided along the length ofthe anchor 200, for example, substantially centrally along the length orcloser to the proximal portion.

Each of the securing members 202, 204 interfaces with a deploymentmechanism 240 that is coupled to an adjustment member 220 disposedwithin the body of the proximal anchor 200. If desired, the adjustmentmember 220 and deployment mechanism 240 could be integrated as onemonolithic member. As shown in FIG. 24, the deployment mechanism 240 iscoupled to the adjustment member 220 by positioning head 224 into slot230. In particular, the head 224 may be slid into slot 230 of thedeployment mechanism 240 in order to interconnect the adjustment member220 and the deployment mechanism 240.

The deployment mechanism 240 interfaces with the securing members 202,204 such that linear movement of the deployment mechanism 240 causes thesecuring members 202, 204 to deploy from the anchor 200. Each securingmember 202, 204 includes at least one ramp or angled surface having aslope. In particular, an inner surface of each securing member 202, 204is arranged with at least one ramp or angled surface having a slope orangle relative to the longitudinal axis of the anchor body 200. Theramps or angled surfaces may be in the form of one or more grooves,recesses, projections, protrusions, or the like in the securing members202, 204. The ramp or angled surface may extend from a first end of thesecuring member 202, 204 to a second, opposite end of the securingmember 202, 204. One ramp or multiple ramps or angled surfaces may beprovided for securing member 202, 204. In one embodiment, the deploymentmechanism 240 is coupled to securing member 204 by sliding tongue 216into groove 212 of securing member 204. Similarly, the deploymentmechanism 240 may be coupled to securing member 202 by sliding angledtongue 218 into groove 210 of securing member 202.

It is contemplated that the slope of the ramped surfaces on securingmember 202, 204 can be equal or can differ from one another. The rampscan serve to move the securing members 202, 204 when the deploymentmechanism 240 is linearly translated between the securing members 202,204. For example, as the deployment mechanism moves distally, the rampedsurfaces 216, 218 of the deployment mechanism 240 push against theramped surfaces 210, 212 of the securing members 202, 204 pushing thesecuring members 202, 204 outwardly into the expanded position. Itshould also be noted that the expansion of the securing members 202, 204can be varied based on the differences in the dimensions of the rampedsurfaces.

The adjustment member 220 is adapted to be driven along a longitudinalaxis of proximal anchor 200 while coupled to deployment mechanism 240.More specifically, when adjustment member 220 is coupled to deploymentmechanism 240 and disposed within the body of the anchor 200, a tool maybe inserted into a recess 280 (e.g., a torx-shaped) in the proximal endof the anchor 200. As an axial force is applied to the adjustment member220, the adjustment member 220 and deployment mechanism 240 are driventowards the distal portion of proximal anchor 200, as shown in thebottom view of FIG. 25. When adjustment member 220 and deploymentmechanism 240 are advanced towards the distal portion of anchor 200 bythe tool, tongues 216, 218 slide along grooves 210, 212, respectively,to force the securing members 202, 204 to radially deploy from theirrespective openings 206, 208.

One or more angled projections 260 are configured to engage partialthreads 214 arranged on an inner surface of proximal anchor 200 toprovide for ratchet-like advancement of the adjustment member 220,deployment mechanism 240, and corresponding securing members 202, 204.The angled projections 260 prevent the adjustment member 220 from movingtowards the proximal end of the anchor 200 when engaged with the threads214 on the interior of the anchor 200. The angled projections 260 may bepositioned on a proximal-most end of the adjustment member 220 or at anysuitable location along the length of the adjustment member. As shown,two opposite angled projections 260 may be provided to engage with twothreaded portions 214 located inside the anchor 200. Any suitable numberof angled projections 160 may be provided in any desirable orientation.

In the event that the securing members 202, 204 need to be retracted orcollapsed back into the body of the anchor 200 (e.g., to adjust theposition or remove the anchor 200), the adjustment member 220 may berotated (e.g., about 90°) such that the angled projections 260 no longeralign with the threads 214 on the inner surface of the anchor 200. Inother words, the adjustment member 220 is rotated such that the angledprojections 260 align with at least one smooth portion 215 on the innersurface of the anchor 200 such that the adjustment member 220 ispermitted to move proximally, thereby allowing the securing members 202,204 to retract. In order to rotate the adjustment member 220, a tool maybe threaded into the internal threads of the adjustment member 220.

Although two securing members 202, 204 are shown, it is envisioned thatany suitable number, size, and type of securing members may be selectedto obtain the desired fixation and press-fit type anchoring whendeployed or expanded in the bone. In particular, the expandable distalportion 250 may include one or more plates, projections, extensions,spikes, teeth, pointed members, or the like configured to emerge fromwithin the body of the expandable anchor 200. Moreover, the securingmembers 202, 204 may be generally flat, contoured, provided with surfaceroughening or teeth, or have any characteristics to enhance locking ofthe distal portion 250 of the expandable anchor 200 when expanded.Moreover, the securing members 202, 204 may be offset and parallel,in-line and parallel, non-parallel, radially extending around theperiphery of the anchor, or of any other suitable configuration. Thus,there can be more than two securing members, at various angles, andeither inline or offset to varying degrees. The securing members 202,204 may deploy or move out radially without axial translation orrotation of the securing member 202, 204 themselves. It is alsoenvisioned that the securing members 202, 204 may be configured toprovide for axial translation and/or rotation as well.

It should be appreciated that the role of the expandable mechanisms ofthe proximal anchor 200 and intramedullary nail 100 can be reversed.More specifically, according to a further embodiment, the proximalanchor 200 may be adapted to be inserted into the intramedullary canalof a femur shaft to provide distal locking, while the nail 100 may beadapted to be inserted into the femur neck. Also, as described elsewhereherein, the intramedullary system 10 including the expandableintramedullary nail 100 and expandable anchor 200 may be used for anysuitable bones or long bones. Thus, even though the descriptiongenerally refers to treatment of a femur, the systems, devices, andmethods may be equally applied to any other long or hollow bonestructure. It is also contemplated that the expansion mechanismsdescribed herein may have applicability in other areas including thoseoutside of long bone applications.

Trochanteric Nail

FIG. 26 depicts a trochanteric nail 700 in an un-deployed state inaccordance with an alternative embodiment. Trochanteric nail 700 has endcap 704 that is adapted to receive a tool 706, as shown in FIG. 27. Thetool is adapted to provide distal locking by rotating end cap 704 toradially deploy spikes 708 from body 702. The spikes 708 are adapted toengage the inner surface of an intramedullary canal in which nail 700 isimplanted. Body 702 also includes through-hole 710 that is sized andshaped to receive a femur neck nail 712 adapted for proximal locking.Femur neck nail 712 is essentially a smaller size of trochanteric nail700, wherein femur neck nail 712 has the same elements and functions astrochanteric nail 700. Therefore, those skilled in the art willappreciate that the following discussion of trochanteric nail 700equally applies to femoral neck nail 712.

FIG. 28 shows end cap 704 having holder retaining features 714 forreceiving a correspondingly size and shaped projection arranged on thehead of tool 706. End cap 704 has a threaded inner surface 730 so thatit can be threaded to the threaded end 716 of the adjustment rod 718depicted in FIG. 29. The adjustment rod 718 is housed within nail body702 and adapted to move longitudinally within the nail body. Similar toadjustment rod 116 at the beginning of this disclosure, FIG. 29 showsadjustment rod 718 having a lateral opening 720, which has alongitudinal length that is longer than the diameter of femoral necknail 712. The lateral opening 720 allows femoral neck nail 712 to passthrough nail body 702 of trochanteric nail 700, while still allowingadjustment rod 718 to longitudinally move within nail body 702.

As further shown in FIG. 29, the distal portion of adjustment rod 718 isarranged with a first plurality of articulating ramps 722 and a secondplurality of articulating ramps 723. Articulating ramps 722 radiallydeploy spikes 708 in one direction while the second plurality ofarticulating ramps 723 deploy other spikes 708 in the other direction,as shown in FIG. 27. Each of the articulating ramps 722 is adapted to bereceived by an articulating slot 770 arranged on the outer surface ofspike 708. The articulated slot can be seen in FIG. 30. Once received, acaptivator 724 is fitted onto the distal portion of adjustment rod 718.When end cap 704 is rotated (e.g., clockwise or counter-clockwise) bytool 706, adjustment rod 718 move towards the proximal portion of body702, thereby causing each spike 708 to engage captivator 724. Inresponse to engaging captivator 724, the first and second plurality ofarticulating ramps 722, 723 slide along their articulating slots 770arranged on spikes 708, which then forces each of the spikes to beradially deployed from body 702 through their respective openings 730.Spikes 708 contact an inner surface of the intramedullary canal toprovide distal locking.

Although the invention has been described in detail and with referenceto specific embodiments, it will be apparent to one skilled in the artthat various changes and modifications can be made without departingfrom the spirit and scope of the invention. Thus, it is intended thatthe invention covers the modifications and variations of this inventionprovided they come within the scope of the appended claims and theirequivalents. It is expressly intended, for example, that all rangesbroadly recited in this document include within their scope all narrowerranges which fall within the broader ranges. It is also intended thatthe components of the various devices disclosed above may be combined ormodified in any suitable configuration.

What is claimed is:
 1. A method for stabilizing a long bone, the methodcomprising: inserting an expandable intramedullary nail into anintramedullary canal of a long bone in a contracted position, theintramedullary nail having a proximal portion and a distal portion, theproximal portion having an opening extending therethrough, and thedistal portion having one or more expandable fixation members disposedin the intramedullary nail, one of the one more expandable fixationmembers extending from a first end to a second end along a longitudinalaxis of the intramedullary nail; inserting a proximal anchor through theopening in the intramedullary nail and substantially transverse to theintramedullary nail to securely anchor the proximal portion ofintramedullary nail; and deploying the one or more fixation members toan expanded position by mechanical actuation of the expandableintramedullary nail such that the one or more fixation members radiallyextend from the intramedullary nail to securely anchor the distalportion of intramedullary nail in the intramedullary canal, wherein,when deployed, the first end and the second end of the expandablefixation member are extended outwardly the same distance from thelongitudinal axis of intramedullary nail, wherein deploying the one ormore fixation members is performed by inserting an adjustment rod havingat least one ramped surface into the intramedullary nail such that theat least one ramped surface engages at least one of the fixationmembers.
 2. The method of claim 1, wherein the intramedullary nailfurther includes an actuation member, wherein the one or more fixationmembers are deployed by moving the adjustment rod longitudinally throughthe nail body.
 3. The method of claim 2, further comprising rotating theactuation member positioned within the adjustment rod to linearlytranslate the adjustment rod.
 4. The method of claim 2, wherein a distalportion of the adjustment rod is arranged with a plurality of angledtongues or grooves configured to engage with corresponding angledgrooves or tongues on the one or more fixation members, and whereintranslational movement of the adjustment rod causes the one or morefixation members to deploy to the expanded position.
 5. The method ofclaim 4, wherein the plurality of angled tongues or grooves include atleast two angled ramps spaced apart from one another and angled in thesame direction.
 6. The method of claim 1, further comprising expandingthe proximal anchor.
 7. The method of claim 6, wherein a distal portionof the proximal anchor has one or more expandable securing membersdisposed in the anchor in a contracted position, wherein, uponmechanical actuation of the one or more securing members, the one ormore securing members radially extend from the anchor to an expandedposition to securely anchor the proximal portion of intramedullary nail.8. The method of claim 6, wherein the expandable proximal anchorincludes a cannulated elongate body, an actuation mechanism extendinglongitudinally through the elongate body, and at least one expandablesecuring member engaged with the actuation mechanism, wherein uponlinear movement of the actuation mechanism, the at least one securingmember deploys from the elongate body.
 9. The method of claim 8, whereinthe actuation mechanism includes an adjustment member connected to adeployment member, and wherein the at least one securing member deploysinto the expanded position when an axial force is applied to theadjustment member.
 10. The method of claim 9, wherein the deploymentmember is arranged with at least one angled tongue or groove configuredto engage with a corresponding angled groove or tongue on the at leastone securing member, and wherein translational movement of thedeployment member causes the at least one securing member to deploy tothe expanded position.
 11. The method of claim 1, wherein the one ormore expandable fixation members deploy from the intramedullary nailwith continuous and discrete adjustments.
 12. The method of claim 1,wherein the long bone is a femur, tibia, fibula, humerus, radius, ulna,or phalange.
 13. A method for stabilizing a long bone, the methodcomprising: inserting an expandable intramedullary nail into anintramedullary canal of a long bone, the intramedullary nail comprisingan elongate nail body having a proximal portion and a distal portion, anelongate adjustment rod extending through the nail body, and anactuation member, the proximal portion having an opening extendingtherethrough, and the distal portion having one or more expandablefixation members disposed in the nail body in a contracted position, oneof the one more expandable fixation members extending from a first endto a second end along a longitudinal axis of the intramedullary nail;inserting an expandable proximal anchor through the opening andtransverse to the intramedullary nail to secure the proximal portion ofthe intramedullary nail; and deploying the expandable fixation membersby rotating the actuation member, thereby causing the adjustment rod tolinearly translate through the nail body, and the one or more fixationmembers to radially extend from the intramedullary nail to an expandedposition to securely anchor the distal portion of intramedullary nail inthe intramedullary canal, wherein, when deployed, the first end and thesecond end of the expandable fixation member are extended outwardly thesame distance from the longitudinal axis of intramedullary nail, whereindeploying the one or more fixation members is performed by inserting theadjustment rod having at least one ramped surface into theintramedullary nail such that the at least one ramped surface engages atleast one of the fixation members.
 14. The method of claim 13, wherein adistal portion of the adjustment rod is arranged with a plurality ofangled tongues or grooves configured to engage with corresponding angledgrooves or tongues on the one or more fixation members, and whereintranslational movement of the adjustment rod causes the one or morefixation members to deploy to the expanded position.
 15. The method ofclaim 13, wherein the expandable proximal anchor includes a cannulatedelongate body, an actuation mechanism extending longitudinally throughthe elongate body, and at least one expandable securing member engagedwith the actuation mechanism, and wherein upon linear movement of theactuation mechanism, the at least one securing member deploys from theelongate body.
 16. The method of claim 15, wherein the actuationmechanism includes an adjustment member connected to a deploymentmember, and the at least one securing member deploys into the expandedposition when an axial force is applied to the adjustment member. 17.The method of claim 16, wherein the deployment member is arranged withat least one angled tongue or groove configured to engage with acorresponding angled groove or tongue on the at least one securingmember, and wherein translational movement of the deployment membercauses the at least one securing member to deploy to the expandedposition.
 18. The method of claim 16, wherein the adjustment memberincludes one or more angled projections configured to engage partialthreads arranged on an inner surface of the proximal anchor to providefor ratchet-like advancement of the adjustment member.
 19. The method ofclaim 18, further comprising rotating the adjustment member such thatthe angled projections align with at least one smooth portion on theinner surface of the anchor, thereby permitting the adjustment member tomove proximally and allowing the at least one securing member toretract.
 20. A method for stabilizing a long bone, the methodcomprising: inserting an expandable intramedullary nail into anintramedullary canal of a long bone, the intramedullary nail comprisingan elongate nail body having a proximal portion and a distal portion, anelongate adjustment rod extending through the nail body, and anactuation member, the proximal portion having an opening extendingtherethrough, and the distal portion having one or more expandablefixation members disposed in the nail body in a contracted position, oneof the one more expandable fixation members extending from a first endto a second end along a longitudinal axis of the intramedullary nail;inserting an expandable proximal anchor through the opening andtransverse to the intramedullary nail, the proximal anchor having acannulated elongate body, an actuation mechanism extendinglongitudinally through the elongate body, and at least one expandablesecuring member engaged with the actuation mechanism; deploying the oneor more expandable fixation members from the intramedullary nail byrotating the actuation member and thereby moving the adjustment rodlongitudinally through the nail body, wherein the one or more fixationmembers radially extend from the intramedullary nail to an expandedposition to securely anchor the distal portion of intramedullary nail inthe intramedullary canal, wherein, when deployed, the first end and thesecond end of the expandable fixation member are extended outwardly thesame distance from the longitudinal axis of intramedullary nail, whereindeploying the one or more fixation members is performed by inserting theadjustment rod having at least one ramped surface into theintramedullary nail such that the at least one ramped surface engages atleast one of the fixation members; and deploying the at least oneexpandable securing member from the elongate body of the anchor bylinear movement of the actuation mechanism, wherein the at least oneexpandable securing member radially extends from the anchor to anexpanded position to securely anchor the proximal portion ofintramedullary nail in the intramedullary canal.